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NCT04697628 · ClinicalTrials.gov registry record · Phase 3
Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
A Phase 3 study of Cervical Cancer, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 502
- Enrollment target
- 20
- Study locations
NCT04697628: Completed Phase 3 study of Cervical Cancer, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
NCT04697628 is a Phase 3 study of Cervical Cancer that has completed, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 502 participants, below the 567-participant average among 144 other Cervical Cancer trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04697628, a Phase 3 study of Cervical Cancer, has completed, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 502 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.
Primary Outcome
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.
Conditions Studied
Interventions
- DRUG gemcitabine
- DRUG vinorelbine
- DRUG topotecan
- DRUG tisotumab vedotin
- DRUG irinotecan
Study Locations (20)
Kentucky
- Norton Cancer Institute, Downtown - Louisville
- Norton Hospital - Louisville
- Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD - Louisville
- Norton Cancer Institute, St. Matthews Campus - Louisville
- Norton Cancer Institute - Louisville
- Norton Women's & Children's Hospital - Louisville
Arizona
- Arizona Oncology Associates, PC - HAL - Glendale
- Arizona Oncology Associates P.C. - NAHOA - Phoenix
- Arizona Oncology Associates, PC - HAL - Phoenix
- Arizona Oncology Associates, PC - HAL - Scottsdale
- Arizona Oncology Associates, PC - HAL - Tempe
California
- University of California Irvine Health - Irvine
- UC Irvine Health (Investigator Site File Location) - Orange
- University of California Irvine Health - Orange
- Olive View - UCLA Medical Center - Sylmar
Illinois
- Northwestern Medical Group - Chicago
- Northwestern Memorial Hospital - Chicago
Connecticut
- Yale University School of Medicine - New Haven
Florida
- Broward Health Medical Center - Fort Lauderdale
Georgia
- Georgia Cancer Center at Augusta University - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2026-01-15 |
| Phase | Phase 3 |
What the finished NCT04697628 record still lists
NCT04697628 is an interventional study that assigns participants to a tested intervention. The registered 502 participants enrollment target is mid-sized for trials with a published cap, below the 567-participant average among 144 other Cervical Cancer trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Cervical Cancer appearing as the primary indexed condition, and to 5 interventions - of which gemcitabine is the first listed.
NCT04697628 names 20 study sites across 7 states, led by Kentucky, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04697628 about?
NCT04697628 is a clinical study titled "Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer". This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will...
What is the current status of trial NCT04697628?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 502 participants. The study started on 2021-02-22. Estimated completion is 2026-01-15.
What conditions does trial NCT04697628 study?
This clinical trial studies the following conditions: Cervical Cancer.
What interventions are being tested in trial NCT04697628?
The interventions under investigation include: gemcitabine (DRUG), vinorelbine (DRUG), topotecan (DRUG), tisotumab vedotin (DRUG), irinotecan (DRUG).
Who is sponsoring clinical trial NCT04697628?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04697628 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cervical Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04697628's enrollment target sits among peer trials
502 28th of 144 higher than 117 of 144 other Cervical Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)
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